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Ramesh Shankar
Wednesday, July 7, 2021, 08:00 Hrs  [IST]

The Indian government and two US vaccine makers, Pfizer and Moderna, have been at loggerheads for some time over the contentious issue of granting indemnity to these vaccine manufacturers for supplying their Covid-19 vaccines to India. Multiple rounds of discussions have already taken place between the Indian government and these two vaccine makers over the issue. But, what has remained unresolved so far is the question of indemnity which, in legal terms, refers to an exemption from liability for damages. Getting indemnity, in this case, means that the companies cannot be sued on account of any adverse events after vaccination. This will make the vaccine makers immune to any kind of monetary or other costs of compensation filed in India with respect to their vaccine doses. During the multiple negotiations with Indian authorities, these two vaccine manufacturers have been demanding to grant indemnity against legal proceedings on the lines of what has been allowed in other countries, including the US and UK. The US, which began vaccinating its people in December, was the first country to provide such legal protection to Covid-19 vaccine manufacturers. The UK too has granted indemnity to vaccine manufacturers. And the World Health Organization has a special compensation programme for low-income countries covered under its COVAX facility.

But, the Indian drug regulator has not granted indemnity against the costs of compensation for severe side effects to the manufacturers of any of the three Covid-19 vaccines - Covishield, Covaxin and Sputnik V - to which it has given emergency use authorisation. For clinical trials, Indian law has laid out rules and a formula for grant of compensation in case of injury or death of any trial subject. But when a vaccine is approved for commercial use, there is no specific provision under the Drugs and Cosmetic Act for compensation. However, beneficiaries seeking compensation can file petitions before legal forums, such as consumer courts or a High Court. Also, the drug regulator can take action under law for violation of any clause when a registration certificate is granted for import of vaccines. But, if the government now grants indemnity to foreign vaccine makers such as Pfizer and Moderna, it may have to grant it to the Indian vaccine makers such as Serum Institute of India and Bharat Biotech as well to maintain a standard policy. Making an effort to vaccinate faster to bend the pandemic curve, the Indian government has already waived off the requirement of India-specific trials for foreign vaccines approved by specific countries and WHO for emergency use. On June 29, Indian drug authorities approved Moderna’s application for emergency use authorization of its vaccine mRNA-1273, thereby clearing the path for importing foreign regulator-approved Covid vaccines to India without bridging clinical studies. The country is now staring at the prospect of the more dangerous third wave of the pandemic. It has to vaccinate faster to prevent further fatality from the pandemic. So, there is an urgent need to expand its vaccination campaign, which is facing delay due to acute shortage of vaccines. Given the gravity of the situation, the Indian government has to pull out all the stops to fill the growing gap between the supply and demand of the Covid-19 vaccine. Reports emanating from the government sources point to the prospect of granting indemnity to the foreign vaccine makers. It is a fact that this will boost the government’s vaccination programme and also make the vaccines more affordable as the manufacturers will not have to worry about insurance or claims-compensation-related elements. Even though there are risks in granting indemnity to the foreign vaccine makers, the benefits far more outweigh any risks in the risk-benefit ratio in vaccination. According to reports, the government is seriously examining the request of the foreign vaccine makers and all reports indicate that it may eventually grant indemnity to them. Any decision on the issue should be in the larger interest of people and on merit.


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